Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
Post: Associate Director CMC
JOB DESCRIPTION:
THE POSITION:
• Prepares global CMC development plans in collaboration with line functions and the head of EPD Drug Product Development.
• Leads CMC activities for DPD together with team(s) of functional representatives from various departments across the division and external parties.
• Serves as a CMC spokesperson for DPD-CMC functions and ensures information flow amongst the project primarily Brand teams, TA strategy teams and various line functions, and informs management of plans, risks and progress through regular communications.
• Builds relations and works with: Clinical, Regulatory, Operations, Quality, and Commercial organizations and external parties.
• Develops, implements and follows reviews lessons learned; establishes success criteria and metrics at the beginning of a project; uses metrics to manage and communicate project accomplishments
• Creates new ideas and drives ideas in process from idea to green housing; liaises with other functions to build business cases. Performs and stimulates technology scouting.
CORE JOB RESPONSIBILITIES:
- Responsible for planning and controlling assigned budgets (capital, projects, functional) ensuring that budget targets are met also in conjunction with external service providers.
- Takes CMC Team leadership, development and execution of the project strategy and is accountable for the budget and overall CMC quality of the assigned projects.
- Represents the team at the project (brand) team meetings, and informs CMC Management of plans, risks and progress through regular communications.
- Ensures high quality science, technology and deliverables, ensuring compliance with respective regulatory and quality requirements.
- Reviews and develops contracts with external parties like: TPMs, consultants, academia and obtains resources from Abbott internal functional areas.
- Presents and meets customers on national level; identifies opinion leaders, presents to PC on a regular basis.
- Demonstrates a strong personal capacity for learning new aspects of the business and encourages others to do the same.
- Presents at scientific conferences mainly at global level; constantly provides presentations and up-dates to brand team.
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POSITION ACCOUNTABILITY / SCOPE:
* Reports directly to the head of the Drug Product Development department and is member of project/brand teams.
* Is accountable for success of assigned CMC part development projects and transfer to MS&T.
* Key contributor for successful filings of high quality CMC dossiers and approval of products.
* This position has a significant impact on the end results for successful completion of the assigned project.
MINIMUM EXPERIENCE / REQUIREMENTS
1) University Exam in natural sciences (e.g. pharmacy, chemistry, biotechnology, food chemistry), Masters Degree at least 6 years of experience within different CMC functions
2) PhD Degree and 4 years experience within different CMC functions.
Additional info:
Qualification: B.Sc, B.Pharm
Experience:5+ years
Location: Mumbai
Job Type: Clinical Research
Industry type: Pharma
Click here: Apply Online
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